Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1019-2015Class II

Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1

Sunrise Medical, Inc. / initiated 2014-12-19 / Terminated / root cause: design

Sunrise Medical (US) LLC began a recall of Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1 on . FDA classified it as Class II and gives the reason as "There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1019-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
Product
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
Product code
IOR Wheelchair, Mechanical
Reason for recall
There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs.
Root cause tag
design
FDA root cause
Device Design
Action
Sunrise Medical sent an Urgent Medical Device Field Correction letters dated December 19, 2014 to the two affected distributors. The letter identified the affected product, problem and actions to be taken. For question contact Sunrise Medical Regulatory Affairs at either (559)294-2840.
Quantity in commerce
3
Distribution
Nationwide Distribution in the states of CO and ME.
Product codes and lots
Serial numbers: RZ-006261, RX-009856, RZ-005964

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1019-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1019-2015Class IITerminatedVoluntary: Firm initiated
Z-1020-2015Class IITerminatedVoluntary: Firm initiated